Role summarysr. Manager/associate director, drug substance development and manufacturing will support ml bio solutions, a subsidiary of bridgebio pharma. This position will be responsible for managing outsourced drug substance manufacturing activities at contract suppliers, including process validation, manufacture of raw materials and drug substance for commercial launch, and tech transfer to new vendors to build and maintain the commercial supply chain throughout the product lifecycle. The position will also support submission of global marketing authorization applications and responses to health agency queries.responsibilities(manage multiple cmos and cros to deliver bulk starting materials, intermediates, and drug substance of sufficient quality and quantity to meet corporate and regulatory requirements. Maintain in-depth knowledge of chemical steps, manufacturing processes, and quality controlsestablish and maintain business relationships with cros and cmos that are appropriate for performing process validation and commercial supply requirementslead late-stage drug substance process finalization, validation, and commercial-scale manufacturingidentify and lead key process problem resolution activities and process improvement initiativeswork closely with quality assurance function to develop and operate appropriate cmc procedures, and to ensure product meets established quality standardscreate and disseminate technical transfer information required by cros and cmos to develop and scale up chemical processes and develop and validate analytical methodssupport authorship, review, and response to queries on all module 3 drug substance development sections of ctd. Contribute to the overall regulatory control strategysupport a culture of continuous improvement and high-performance teamworkqualificationsminimum of a phd (ideally chemistry or chemical engineering) with 7+ years relevant experience, or a bs/ms with 10+ years relevant experiencedemonstrated chemistry development at an industrial scaledemonstrated experience in managing drug substance chemical development, process validation, and manufacturing in support of marketing applications and commercial productionstrong aptitude and demonstrated experience in synthetic organic chemistryworking knowledge of analytical method development and validationfamiliarity with fda and ich guidelines for inds/ndas/maas. Thorough understanding of cgmp, quality, and regulatory requirements for drug substance manufacturingability to effectively interface with and/or manage highly skilled internal staffability to work independently and in a team. Ability to build good work relationshipsstrong attention to detail and time management skills. Excellent oral and written communication skillsup to 20% travel may be requiredadditional requirementstravel up to 20% may be required
#j-18808-ljbffr